Core Viewpoint - Merck has received approval from the National Medical Products Administration (NMPA) in China for its breakthrough therapy, ASI (injectable sotatercept), aimed at treating adult patients with pulmonary arterial hypertension (PAH) classified as WHO functional class (FC) II-III, to improve their exercise capacity and WHO functional class [1] Group 1 - ASI is a novel biological agent targeting the underlying causes of PAH [1] - The approval is based on data from the Phase III clinical trial STELLAR [1]

Core Insights - Merck announced the temporary import approval of sotatercept (WINREVAIR) for clinical use in China, supported by local policies aimed at facilitating the import of urgently needed medical products [1][2] - Sotatercept is the first and only activin signaling inhibitor (ASI) for treating pulmonary arterial hypertension (PAH), which has received multiple regulatory designations including breakthrough therapy and orphan drug status in the US and EU [1] - PAH is a rare and progressive vascular disease that can lead to severe health complications, including right heart failure, if not treated effectively [1] Group 1 - The approval of sotatercept is expected to provide a new treatment option for PAH patients, addressing the urgent need for innovative therapies as survival rates have not significantly improved over the past decade [2] - Professor Liu Zhihong highlighted that the five-year mortality rate for newly diagnosed PAH patients remains high at 40%, emphasizing the necessity for new treatment mechanisms [2] - Sotatercept has already been implemented in the Boao Lecheng International Medical Tourism Pilot Zone, indicating its growing presence in the Chinese market [2]